SWOG-S0221 is a new Phase III adjuvant Intergroup trial evaluating chemotherapy schedules.the combination dose-dense arm of CALGB-9741 was selected for the initial randomization instead of the sequential arm. On it, AC is given every two weeks with growth factor support or every week. The every two seek schedule was previously shown to be as good as every three week administration. In the second randomization, paclitaxel every two weeks is compared to paclitaxel every week.
There are multiple assumption that are being tested, including weekly chemotherapy versus every two week and different schedules of paclitaxel, oral chemo, metronomic approach to chemo. Unfortunately, it is not known which arm the patient will randomize to since the insurance approval is being sought as a prerequisite to enrollment into the trial. However each arm includes experimental hypotheses. It is expert opinion that each one needs to be tested, which is being, in fact, done on this trial. Thus, the trial is experimental/ investigational.
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